Brexit – Is Your Life Sciences Company Prepared for the Changes to the CE Mark?

To Brexit or Not to Brexit – that is the question.

Brexit (United Kingdom’s separation from the European Union) is a complicated subject that has many implications including trade, immigration, and transportation.

On June 23, 2016, United Kingdom citizens voted to leave the EU. The UK intended to withdraw from the EU on March 29, 2019, however the date has now been moved to October 31, 2019. How the withdrawal occurs, remains to be seen. The two scenarios often referred to include:

Hard Brexit or No Deal Brexit – UK leaves EU with a clean break from EU’s regulations; no transition period and no, or few, agreements in place.
Soft Brexit – Some alignment remains between UK and the EU.

Brexit and its impact on Life Sciences companies

Brexit also has a potential impact to life sciences companies doing business in the EU. There are several considerations to address if a company received a CE Mark for its product(s) from a UK-based notified body and distributes that product to EU countries. Based on what is known now, and should a No Deal Brexit occur, after 31 October 2019, affected product may no longer be recognized by the EU as the UK will no longer be part of the EU. These medical devices could be delayed or interrupted from passing into the EU. It’s uncertain if this will happen. However, this may drive life sciences companies to proactively transfer their conformity assessment certificates to an EU27 notified body prior to 31 October 2019. Doing this means that the license number of the notified body will change. This, in turn, will trigger a need for relabeling existing product IFUs (instructions for use) and labels that carry the CE Mark.

Of course, there are resources and costs associated with these changes; including regulatory filings, quality documentation updates, labeling revisions, distribution strategies, etc. The relabeling transition timeline for product moving from a UK-based notified body to an EU27 notified body is still unknown. With a Soft Brexit scenario, there may be a lengthier amount of time to revise product labeling.

How will Brexit affect existing products marketed in the UK?

Life sciences companies will also want to obtain clarification on product distributed solely in the UK. Can existing product covered by a UK-based Notified Body number continue to be placed on the market in the UK after 31 October 2019? To that end, it is important to keep current on Brexit’s status. It will be prudent for affected companies to engage with their regulatory affairs, legal, and supply chain associates to determine a Brexit strategy that avoids disruption of product distribution.

Additional questions that may need to be answered include:

How are customers outside of the EU impacted, if at all? Do customers in geographies outside of the EU receive CE marked product? If so, will they continue to accept CE marked product from a UK-based notified body?
Is product inventory with a UK-based notified body number able to be distributed in the EU if it’s manufactured and already at a hospital / clinic or stored at a distribution warehouse within the EU prior to 1 November 2019?

A careful assessment should be conducted to answer these questions and others to help determine a proactive Brexit strategy for life sciences companies.

Argos Multilingual is experienced in guiding its customers through regulatory changes. For more information on how we can help you transition your business and content to continue to be compliant in the European Union, contact us.